The 10-centre trial will investigate the
efficacy of the kiwifruit extract Kivia in patients
diagnosed with irritable bowel syndrome (IBS) with
constipation.

Vital Foods already markets the same product
under the brand name Phloe in the over-the-counter market in
New Zealand.

Irritable bowel syndrome is regarded as a
major women’s health issue affecting about one in 10
people, mostly women aged between 20 and 50 years. There are
limited treatment options for the condition, which presents
as recurring abdominal pain or discomfort associated with
either constipation or diarrhoea that lasts for at least six
months.

The double-blind, randomised, placebo-controlled
Phase III clinical trial, to establish the efficacy of
Kivia, will recruit 180 patients who will be monitored and
treated over a three-month period. Recruitment will take
place at 10 sites across New Zealand and Australia. Patients
are already being admitted to the trial in Auckland,
Melbourne, Sydney, Brisbane, and Adelaide. Two other New
Zealand centres will start recruiting patients this month.
Results are expected before the end of this year and if
successful, will lead to entry of the product into
international markets with a specific health indication for
the treatment of IBS.

Vital Foods’ chief executive
Justus Homburg said Phloe is one of the most extensively
investigated natural products for digestive
health.

“This clinical trial is designed to build on the
results of previous studies that focussed on relief of
constipation and showed that Phloe relieved abdominal
bloating, pain and flatulence in people with some of the
symptoms also associated with IBS,” said Mr Homburg.
“These included four randomised, double-blind,
placebo-controlled trials conducted in the United States and
in China and three randomised open-label trials conducted in
Japan.”

Gastroenterologist Dr Alasdair Patrick, who is
managing the trial site at Auckland’s MacMurray Centre,
says the new study is a significant step in identifying a
successful treatment for the estimated 2.7 million people in
New Zealand and Australia that suffer from IBS.

“Dietary
intervention is already a mainstay of our treatment of IBS.
Adjusting the intake of fibre, carbohydrate and fat in the
diet can be effective, but IBS remains difficult to treat
and is an ongoing burden for many people that impacts on
their daily quality of life. This trial is a step towards
identifying an effective treatment.”

Dr Iona Weir, Vital
Foods’ chief scientific officer, says international
investigations into the cause of IBS to date have yielded no
clear results.

“However, while the causes of IBS have
not been clearly identified, we do know what factors can
contribute to symptoms. In earlier studies, Phloe has been
shown to relieve some of those symptoms and what is most
exciting is that it appears the proprietary kiwifruit
extract in the product, zyactinase, may actually modify some
of the contributing factors in the gut.

“We now have an
extensive body of clinical data that supports the efficacy
of Phloe.”

Anyone who is interested in further
information about this clinical trial or who is interested
in participating in the trial should go to: www.theideastudy.com

About
IBSIrritable Bowel Syndrome is a chronic
gastrointestinal disorder estimated to affect between 9 and
23% of the population worldwide. Although it affects
approximately one in 10 people, the International Federation
for Functional Gastrointestinal Disorders reports that most
IBS sufferers do not seek medical help. Nevertheless, in the
United States between 2.4 and 3.5 million annual physician
visits are for patients diagnosed with IBS, and it has
become a major women’s health issue.

About
PhloeOne of the most effective, gentle laxative
over-the-counter therapies currently available, Phloe is
made from green kiwifruit using Vital Foods’ proprietary
processing technology. Studies have confirmed that Phloe
improves general digestive health, minimises episodes of
occasional constipation, and assists in reducing abdominal
discomfort. Phloe has few, if any, of the side effects
commonly associated with harsher laxatives. It has been
recently made a standard preparation for many patients
undergoing radiation therapy for prostate and bowel cancer
in New Zealand.

About KiviaKivia is the same
formulation as Phloe but, if this trial confirms expected
efficacy, it will be marketed internationally with a
specific claim for treatment of IBS.

About Vital
FoodsVital Foods’ was established to provide the
digestive health benefits of kiwifruit through easy to
consume digestive health products for all ages. The
company’s first product on the market was Kiwi Crush, a
frozen kiwifruit drink that is sold as a digestive aid in
supermarkets in New Zealand. Research into its therapeutic
effects led to the development of Phloe, also based on
kiwifruit, which was launched in 2007 and is now available
in pharmacy, healthfood and grocery outlets in New Zealand
and is about to be launched globally through www.digestivephloe.com . Together, the
two products currently make up the highest-selling digestive
health product family sold in New Zealand.

The new
clinical study is a key step towards confirming Kivia as a
treatment of a clinically diagnosed disease internationally,
and, in turn, growing opportunities in the global consumer
healthcare market.

In mid 2011 Nestle took at 18.2% stake
in the company through its wholly-owned Health Sciences
Company. Other shareholders are New Zealand’s largest
kiwifruit company Seeka Kiwifruit Industries, the venture
funds BioPacific Ventures and Inventages, and private
interests.

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